Hip Arthropathy
Conditions
Brief summary
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.
Detailed description
A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty: * Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. * Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
Interventions
DEVICEProsthesis with CoPXE couple.
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
DEVICEProsthesis with CoC torque.
Prosthesis with ceramic-on-ceramic (CoC) torque.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
A single-centre, prospective, randomised, single-blind, comparative, category 2 study of two parallel groups of patients undergoing total hip arthroplasty: * Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. * Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged 18 to 65 years, * Who have signed their consent to participate in the study, * For whom an indication for total hip arthroplasty has been given
Exclusion criteria
* History of hip surgery * Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly) * Hip dysplasia * Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis * Sequelae of neurological disease or stroke * Pregnant or breastfeeding women * Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol * Patient likely not to return for follow-up visits * Patient already included in another therapeutic study protocol * Patient under court protection, guardianship or curatorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| five-year wear thickness of the two friction pairs | Year 5 | The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell |
Countries
France
Contacts
Primary ContactJean LANGLOIS, MD
Outcome results
None listed